RU2005132451A - TABLET OF SPECIAL GEORMETRIC FORM WITH SLOW RELEASE OF ACTIVE SUBSTANCE - Google Patents

TABLET OF SPECIAL GEORMETRIC FORM WITH SLOW RELEASE OF ACTIVE SUBSTANCE Download PDF

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RU2005132451A
RU2005132451A RU2005132451/15A RU2005132451A RU2005132451A RU 2005132451 A RU2005132451 A RU 2005132451A RU 2005132451/15 A RU2005132451/15 A RU 2005132451/15A RU 2005132451 A RU2005132451 A RU 2005132451A RU 2005132451 A RU2005132451 A RU 2005132451A
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tablet according
tablet
core
shell
prednisone
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RU2005132451/15A
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Russian (ru)
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RU2391093C2 (en
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Гай ВЕРГНАЛТ (FR)
Гай ВЕРГНАЛТ
Паскаль ГРЕНИЕР (FR)
Паскаль ГРЕНИЕР
Кристоф ДРАГАН (FR)
Кристоф ДРАГАН
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Джаготек Аг (Ch)
Джаготек Аг
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents

Abstract

A tablet comprising a core containing an active agent, and a coating, the core being disposed within the coating such that the coating has a thickness about a longitudinal axis (X-Y) of about 4.85 to 4.95 mm. The position of the core within the coating dictating that the active agent is released rapidly after a lag time during which time no active agent is released.

Claims (20)

1. Таблетка, в состав которой входят ядро, содержащее лекарственное средство, и оболочка вокруг указанного ядра, причем ядро расположено внутри указанной оболочки таким образом, что толщина оболочки по оси (X-Y) больше, чем толщина оболочки по оси (А-В)), ортогональной оси (X-Y), при этом толщина оболочки по оси (X-Y) выбрана таким образом, что при погружении в водную среду разрушение оболочки и высвобождение лекарственного средства происходит после периода длительностью от 2 до 6 ч.1. A tablet comprising a core containing a drug and a shell around the core, the core being located inside the shell so that the shell thickness along the axis (XY) is greater than the shell thickness along the axis (AB)) , orthogonal axis (XY), while the thickness of the membrane along the axis (XY) is chosen so that when immersed in an aqueous medium, the destruction of the membrane and the release of the drug occurs after a period of 2 to 6 hours 2. Таблетка по п.1, отличающаяся тем, что толщина покрытия по оси (X-Y) составляет по меньшей мере 2,2 мм.2. The tablet according to claim 1, characterized in that the coating thickness along the axis (X-Y) is at least 2.2 mm 3. Таблетка по п.1, отличающаяся тем, что толщина покрытия по оси (X-Y) составляет приблизительно от 2,2 до 2,6 мм.3. The tablet according to claim 1, characterized in that the coating thickness along the axis (X-Y) is from about 2.2 to 2.6 mm. 4. Таблетка по п.1, отличающаяся тем, что оболочка представляет собой нерастворимый в воде или плохо растворимый гидрофобный материал.4. The tablet according to claim 1, characterized in that the shell is a water-insoluble or poorly soluble hydrophobic material. 5. Таблетка по п.1, отличающаяся тем, что оболочка содержит гидрофобные производные целлюлозы и полимеры, включая алкилцеллюлозу, гидроксипропилцеллюлозу, гидроксипропилметилцеллюлозу, карбоксиметилцеллюлозу и их производные, полимерные производные полиметакрила, поливинил-ацетат и полимерные производные ацетата целлюлозы, жирные кислоты, либо их эфиры или соли, длинноцепочечные жирные спирты, полиоксиэтилен алкил эфиры, стеараты полиэтилена, эфиры сахаров, лауроил макрогол-32 глицерил, стеароил макрогол-32 глицерил и т.п.5. The tablet according to claim 1, characterized in that the shell contains hydrophobic derivatives of cellulose and polymers, including alkyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl cellulose and their derivatives, polymer derivatives of polymethacryl, polyvinyl acetate and polymer derivatives of cellulose fatty acids or cellulose acetate, esters or salts, long chain fatty alcohols, polyoxyethylene alkyl ethers, polyethylene stearates, sugar esters, lauroyl macrogol-32 glyceryl, stearoyl macrogol-32 glyceryl, and the like. 6. Таблетка по п.1, отличающаяся тем, что оболочка содержит соль фосфат кальция, глицерил бегенат и поливинилпирролидон, либо их смеси.6. The tablet according to claim 1, characterized in that the shell contains a salt of calcium phosphate, glyceryl behenate and polyvinylpyrrolidone, or mixtures thereof. 7. Таблетка по п.1, отличающаяся тем, что ядро содержит лекарственное вещество и дезинтегрирующее вещество.7. The tablet according to claim 1, characterized in that the core contains a drug substance and a disintegrant. 8. Таблетка по п.1, отличающаяся тем, что она содержит поперечно сшитые поливинилпирролидон и кроскармеллозу натрия.8. The tablet according to claim 1, characterized in that it contains cross-linked polyvinylpyrrolidone and croscarmellose sodium. 9. Таблетка по п.1, отличающаяся тем, что активное вещество представляет собой глюкокортикостероид, выбранный из преднизона, преднизолона или метилпреднизолона.9. The tablet according to claim 1, characterized in that the active substance is a glucocorticosteroid selected from prednisone, prednisolone or methylprednisolone. 10. Таблетка по п.9, отличающаяся тем, что она содержит 1 или 5 мг преднизона.10. The tablet according to claim 9, characterized in that it contains 1 or 5 mg of prednisone. 11. Таблетка по п.10, отличающаяся тем, что она содержит следующие ингредиенты:11. The tablet of claim 10, characterized in that it contains the following ingredients: Ядро таблетки, содержащей 5 мг преднизона:The core of a tablet containing 5 mg of prednisone: ПреднизонPrednisone 8,33%8.33% Моногидрат лактозыLactose Monohydrate 64,47%64.47% Повидон (Povidone)Povidone (Povidone) 6,67%6.67% Кроскармеллоза натрияCroscarmellose sodium 18,33%18.33% Красный оксид железаRed iron oxide 0,5%0.5% Стеарат магния растительного происхожденияPlant Magnesium Stearate 1,0%1,0% Коллоидный диоксид кремнияColloidal silicon dioxide 0,5%0.5%
ОболочкаShell Дигидрат двухосновного фосфата кальцияDibasic Calcium Phosphate Dihydrate 50%fifty% Глицерил бегенатGlyceryl Behenate 40%40% ПовидонPovidone 8,40%8.40% Желтый оксид железаYellow iron oxide 0,1%0.1% Стеарат магния растительного происхожденияPlant Magnesium Stearate 1,0%1,0% Коллоидный диоксид кремнияColloidal silicon dioxide 0,5%0.5%
12. Таблетка по любому из пп.1-11, отличающаяся тем, что после введения пациенту период задержки перед высвобождением лекарственного средства составляет от 2 до 6 ч.12. The tablet according to any one of claims 1 to 11, characterized in that after administration to the patient, the delay period before the release of the drug is from 2 to 6 hours 13. Таблетка по любому из пп.1-11, отличающаяся тем, что она обладает профилем растворения in vitro, установленным при помощи аппарата №2 согласно Фармакопее США при скорости перемешивания, равной 100 об/мин, и в растворяющей среде, состоящей из очищенной воды (500 мл), в котором наблюдается период задержки средней длительностью 4 ч, при этом по меньшей мере приблизительно 80% лекарственного средства высвобождается после 4,5 ч, а 100% высвобождение происходит после 5 ч.13. A tablet according to any one of claims 1 to 11, characterized in that it has an in vitro dissolution profile set using apparatus No. 2 according to the US Pharmacopoeia at a stirring speed of 100 rpm and in a solvent medium consisting of purified water (500 ml), in which there is a delay period of an average duration of 4 hours, with at least approximately 80% of the drug being released after 4.5 hours, and 100% release occurs after 5 hours 14. Таблетка по п.13, где лекарственное вещество выбрано из преднизона, преднизолона или метилпреднизолона.14. The tablet according to item 13, where the medicinal substance is selected from prednisone, prednisolone or methylprednisolone. 15. Таблетка по любому из пп.1-11 и 14, отличающаяся тем, что индивидуальная и меж-индивидуальная вариабельность Тмах составляет менее +/-20%, независимо от того, находится пациент в сытом или голодном состоянии.15. A tablet according to any one of claims 1 to 11 and 14, characterized in that the individual and inter-individual variability of T max is less than +/- 20%, regardless of whether the patient is in a full or starving state. 16. Таблетка по любому из пп.1-11 и 14, отличающаяся тем, что после введения однократной дозы отношение Смах сытое/голодное составляет от 0,7 до 1,43.16. A tablet according to any one of claims 1 to 11 and 14, characterized in that after the administration of a single dose, the C max ratio is full / fasted from 0.7 to 1.43. 17. Таблетка по любому из пп.1-11 и 14, отличающаяся тем, что после введения однократной дозы отношение AUC сытое/голодное составляет от 0,8 до 1,25.17. A tablet according to any one of claims 1 to 11 and 14, characterized in that after the administration of a single dose, the AUC ratio is full / hungry from 0.8 to 1.25. 18. Фармацевтическая упаковка, содержащая таблетки по любому из пп.1-17, вместе с ярлыком или инструкцией о том, что таблетки можно принимать с пищей или без нее (независимо от приема пищи).18. A pharmaceutical package containing tablets according to any one of claims 1-17, together with a label or instruction that the tablets can be taken with or without food (regardless of the meal). 19. Способ лечения артритных болей, аллергий, астмы, болезни Крона, язвенного колита, синдрома раздраженного кишечника и воспалительных заболеваний кишечника путем предоставления нуждающемуся в лечении пациенту таблетки, описанной в любом из пп.1-17, содержащей преднизон, преднизолон или метилпреднизолон.19. A method for treating arthritic pains, allergies, asthma, Crohn’s disease, ulcerative colitis, irritable bowel syndrome and inflammatory bowel diseases by providing a patient in need of treatment with a tablet described in any one of claims 1-17 containing prednisone, prednisolone or methylprednisolone. 20. Способ приготовления таблетки по любому из пп.1-17, включающий стадию формования первого гранулята, содержащего материал оболочки, получение второго гранулята, содержащего материал ядра, формование второго гранулята в виде ядра и напрессовывание первого гранулята вокруг ядра.20. A method of preparing a tablet according to any one of claims 1 to 17, comprising the step of forming a first granulate containing shell material, obtaining a second granulate containing core material, molding the second granulate as a core, and pressing the first granulate around the core.
RU2005132451/15A 2003-04-24 2004-04-23 Slow-release tablet with specified core geometry RU2391093C2 (en)

Applications Claiming Priority (2)

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GB0309342 2003-04-24
GB0309342.4 2003-04-24

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RU2005132451A true RU2005132451A (en) 2006-06-10
RU2391093C2 RU2391093C2 (en) 2010-06-10

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US (6) US8168218B2 (en)
EP (1) EP1631251B1 (en)
JP (1) JP4790597B2 (en)
KR (1) KR101192722B1 (en)
CN (2) CN102525993B (en)
AT (1) ATE512659T1 (en)
AU (1) AU2004231362B2 (en)
BR (1) BRPI0409652A (en)
CA (1) CA2523158C (en)
CY (1) CY1111835T1 (en)
DK (1) DK1631251T3 (en)
ES (1) ES2368066T3 (en)
IL (1) IL171494A (en)
MX (1) MXPA05011446A (en)
PL (1) PL1631251T3 (en)
PT (1) PT1631251E (en)
RU (1) RU2391093C2 (en)
SI (1) SI1631251T1 (en)
WO (1) WO2004093843A1 (en)
ZA (1) ZA200509477B (en)

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